TENA

GUDID 10768702600139

Essity Hygiene and Health AB

Adult nappy

• Primary Device ID: 10768702600139
• NIH Device Record Key: 8c2a4ae6-2dd8-431b-af11-8ee4677bf512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENA
• Version Model Number: IDENTIFI SENSORWEAR M/R
• Company DUNS: 353945611
• Company Name: Essity Hygiene and Health AB
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)722-6659
• Email: essityorders@essity.com
• Phone: +1(866)722-6659
• Email: essityorders@essity.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768702600132 [Primary]
GS1	07322540881394 [Unit of Use]
GS1	10768702600139 [Package]; Contains: 00768702600132; Package: Case [2 Units]; In Commercial Distribution

FDA Product Code

• KPN: ALARM, CONDITIONED RESPONSE ENURESIS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-06
• Device Publish Date: 2016-09-16

On-Brand Devices [TENA]

• 00768702600200: IDENTIFI LOGGER KIT
• 10768702600146: IDENTIFI SENSORWEAR L/XL
• 10768702600139: IDENTIFI SENSORWEAR M/R
• 10768702912836: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 00768702912822: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541245874: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 00768702912808: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541306803: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541306797: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 07322541306780: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar
• 00768702912846: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA Smar